Associate III, Quality Assurance

About This Role

As a QA Associate III, you will apply strong knowledge of cGMP requirements, Biogen Quality Systems, internal   procedures   and your primary quality discipline to support compliant manufacturing operations. You will review and approve documentation that supports batch and cell bank disposition, assess product acceptability for continued processing or distribution, and provide   timely   quality direction on the manufacturing floor. You will partner across Quality, Manufacturing and PO&T to   identify   and resolve quality and compliance concerns, support inspection readiness and advance new product introduction technology transfers and restart programs. You will also provide technical writing and investigation support, including root cause and impact assessments, and may complete selected minor investigation or GCC assessment activities after   demonstrating   the required competencies and with management oversight. This individual contributor role requires sound judgment, mature situational   leadership   and the ability to work independently while collaborating across functions and organizational levels.

What   You’ll   Do

Review and approve batch and cell bank disposition documentation for cGMP compliance and product acceptability

Review executed BPRs, PRCDs/WIs, formulas, recipes, validity rules, MPRs, MSLRs, MSMs, PCDs, PFDs and PARs

Perform manufacturing-floor record review, observations, WORCs and inspection-readiness walkthroughs

Provide quality oversight of manufacturing operations and technical consultation on regulatory and site-procedure requirements

Support resolution of technical and compliance issues or gaps of low to moderate complexity

Support the QA Lead for NPI technology transfers and restart programs

Provide technical writing, investigation support, root cause   analysis   and impact assessment

Support CAPA closure and review or approval of associated documentation with management oversight

Assist   with implementation of Quality Management Systems and   GxP   quality-systems training

Communicate quality issues, recommendations and decisions across Quality, Manufacturing,   Engineering, Warehouse,   and other functions

Who You Are

You are a detail-oriented quality professional who applies sound judgment, regulatory   knowledge   and a practical understanding of manufacturing to protect product quality. You communicate complex information clearly, adapt to changing   priorities   and build productive cross-functional partnerships to resolve issues and   maintain   compliance.

Required Skills

Bachelor’s Degree   required , preferred in a life science discipline

2+ years of related experience working in a quality GMP biopharma or pharma environment

Working knowledge of   GxP   regulations, cGMP   requirements   and relevant FDA/EMA expectations

Understanding of quality systems, quality   concepts   and manufacturing processes

Strong organization,   prioritization   and multi-tasking skills

Excellent written,   verbal   and interpersonal communication skills

Preferred Skills

Investigation, root cause analysis, impact   assessment   and technical writing skills including   d emonstrated   competency in minor investigations, CAPA documentation or GCC assessments

Experience reviewing controlled manufacturing and disposition documentation

Understanding of biopharma or pharma manufacturing processes

Job Level: Professional

Additional Information

The base compensation range for this role is: $69,000.00-$90,000.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being ; including, but not limited to:

Medical, Dental, Vision, & Life insurances

Fitness & Wellness programs including a fitness reimbursement

Short- and Long-Term Disability insurance

A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)

Up to 12 company paid holidays + 3 paid days off for Personal Significance

80 hours of sick time per calendar year

Paid Maternity and Parental Leave benefit

401(k) program participation with company matched contributions

Employee stock purchase plan

Tuition reimbursement of up to $10,000 per calendar year

Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.  Read on  to learn more about our Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.